ZENITH-1试验:口服BCX7353治疗急性遗传性血管性水肿发作具有显著效果

2019-02-25 不详 网络

BioCryst制药公司近日公布了II期ZENITH-1试验的最新数据,包括来自250毫克和500毫克剂量组的新数据。来自ZENITH-1试验的数据证实了先前报道的结果,显示单剂量口服750毫克 BCX7353耐受良好,且优于安慰剂(p <0.05),在治疗急性发作的遗传性血管性水肿(HAE)患者中达到了疗效终点,并证明在三个剂量水平上有明确的剂量反应。

BioCryst制药公司近日公布了IIZENITH-1试验的最新数据,包括来自250毫克和500毫克剂量组的新数据。来自ZENITH-1试验的数据证实了先前报道的结果,显示单剂量口服750毫克 BCX7353耐受良好,且优于安慰剂(p <0.05),在治疗急性发作的遗传性血管性水肿(HAE)患者中达到了疗效终点,并证明在三个剂量水平上有明确的剂量反应。

根据ZENITH-1的结果,该公司计划在2019年第二季度与美国食品药品监督管理局(FDA)会面,并在2019年夏季开始使用750毫克剂量的口服BCX7353进行III期试验。BioCryst首席医疗官William Sheridan博士说:对于急性HAE发作的患者,BCX7353能够在一小时内起效,单剂量药物的效果持续时间超过24小时。基于这些出色的结果,我们计划将750毫克口服BCX7353快速推进到第III阶段试验

先前的数据显示,使用750mg剂量,与安慰剂相比,在口服BCX7353给药后1小时可观察到症状改善和视觉模拟评分(VAS)的改善,并持续24小时。用BCX7353治疗的病例中有64.1%报告无症状或轻微症状,而安慰剂组的发病率为32.3%(p = 0.0038)。


原始出处:

http://www.firstwordpharma.com/node/1626615#axzz5gWnfKeds

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    2019-02-27 小华子
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    2019-02-25 CHANGE

    疗效只是效果的众多方面之一,还要看对患者的获益,包括生活质量等因素共同决定效果的

    0

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